DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.34(a) on or before October 6, 2017. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before October 6, 2017.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been redelegated
to the Assistant Administrator of the DEA Diversion Control Division
("Assistant Administrator") pursuant to section 7 of 28 CFR part 0,
appendix to subpart R.

In accordance with 21 CFR 1301.34(a), this is notice that on
December 9, 2016, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road,
Morgantown, West Virginia 26505 applied to be registered as an importer
of the following basic classes of controlled substances:

Controlled Substance

Drug Code

Schedule

Amphetamine

1100

II

Methylphenidate

1724

II

Oxycodone

9143

II

Hydromorphone

9150

II

Methadone

9250

II

Morphine

9300

II

Fentanyl

9801

II

The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials

[[Page 42121]]

in which the foreign FDF will be compared to the company's own
domestically-manufactured FDF. This analysis is required to allow the
company to export domestically-manufactured FDF to foreign markets.
Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.

Dated: August 28, 2017.

Demetra Ashley, Acting Assistant Administrator.

[FR Doc. 2017-18801 Filed 9-5-17; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).